MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS PHENO; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10849000

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that a malfunction occurred while operating the artis pheno system.The user reported a communication problem between the table and system during a procedure.There is no report of impact to the state of health of any patient or user involved.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.The table up button of the table control module (tcm) of the x-ray system was defective, which meant that the control of the table upward movement was constantly activated.This was detected by the system and, for safety reasons, all movement control via tcm was blocked by the system.This is a specified function that prevents uncontrolled movements of the table and represents a mitigation of the problem.Although this overrode the tcm of the system, it did not affect the movements initiated from the oem table.These continued to function because the trumpf oem table has its own control circuit.After replacing the affected tcm, the system again functioned as specified.The error has not been reported again and a possible general fault that would require corrective action of the installed base could not be determined by the investigation.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected.

• Brand Name: ARTIS PHENO
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 12093167
• MDR Text Key: 259220333
• Report Number: 3004977335-2021-86463
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869046877
• UDI-Public: 04056869046877
• Combination Product (y/n): N
• PMA/PMN Number: K201156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10849000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 06/30/2021
• Supplement Dates Manufacturer Received: 09/07/2021
• Supplement Dates FDA Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1